Peel/Halton 2010 CME

Sheldon Cheskes, MD CCFP(EM) FCFPMedical Director

Sunnybrook – Osler Centre for Prehospital CareLi Ka Shing Knowledge Institute, St. Michael’s Hospital

Co Principal Investigator, Resuscitation Outcomes Consortium, Toronto Regional Rescuenet

Resuscitation Outcomes Consortium (ROC)

What Studies Are Coming Down The Pike?

Previous Trials

ROC Epistry: Cardiac Arrest Data Base ROC PRIMED: Early Vs Late Analysis and

use of ITD ROC HS: Hypertonic Saline in TBI and

Hypovolemic Shock

EMS Providers Views

Enjoy taking part in randomized controlled trials “Lots of work” “Pain in the @@#%” Challenges of randomization, documentation,

and CPR process capture

Overwhelming View

Despite findings of previous ROC RCT “Thirst for a positive trial”

What's Next For ROC EMS Agencies

Cardiac Trials ROC CCC ROC Amiodarone

Trauma Trials ROC Lactate ROC Hypotensive Resuscitation

Upcoming Trial Overview

Science Methodology EMS Challenges

ROC CCC

Trial of Continuous Compressions vs Standard CPR in patient’s with out-

of-hospital cardiac arrest

ROC CCC Science Greater coronary perfusion pressure

associated with greater ROSC in animal and human studies

Interruptions in chest compression reduce CPP

Observational studies suggest at least as effective as standard CPR

Observational trials instituted multiple changes? Impact of CCC

ROC CCC Science

Insertion of advanced airway associated with interruption in CPR

CCF (hands on time) increased in sites using CCC model

Increased CCF associated with increased survival from VF/VT

ROC CCC Methodology

EMS arrival at patient (>18, non –traumatic cardiac arrest, lack of exclusion criteria) with randomization to:

Control group3 cycles of 2 minutes of standard

(30:2) CPRanalysis after each 2 minute CPR

cyclestandard site ventilatory treatment

ROC CCC Methodology

Randomization Group:3 cycles of 2 minutes of CPR using

continuous compressions with no stops for ventilation

Analysis after each 2 minute CPR cycle

ROC CCC Methodology

Ventilation Strategy In Randomization Group: Sites will choose between two ventilation

strategies

Positive pressure ventilation 10 ventilations/minute via BVM with no

CPR interruptions for ventilations

Passive ventilation Oral airway with oxygen via non re-

breather at 15 l/min

ROC CCC MethodologyBoth Groups:

IV or IO with epinephrine or vasopressin given within 5 minutes of ALS arrival

After advanced airway inserted ventilation rate at 10/minute compression rate at 100/minute (current standard) until ROSC or termination of resuscitation

ROC CCC EMS Challenges Maximize CPR process files*** Randomization: cluster and frequency of

cross over ALS medics not intubating for first five

minutes Supraglottic airways: advanced or not? Bagging while doing compressions in

unprotected airway

ROC Amiodarone

Amiodarone (pm101), lidocaine or neither for out-of-hospital cardiac

arrest due to ventricular fibrillation or tachycardia

ROC Amiodarone Science

Little evidence that anti-arrythmics have any impact on survival from OHCA

Given lack of evidence question is not just which anti-arrythmic should be used but should any be used?

Since no evidence of improvement in survival to discharge inclusion of placebo arm is required

ROC Amiodarone Science Three staged model of cardiac arrest Antiarrythmics necessary to correct

electrical abnormalities Previous trials of antiarrythmics delayed

administration until well into metabolic phase

Optimal approach would be administration during electrical or circulatory phase

ROC Amiodarone Science

ALIVE: amiodarone recipients more likely to survive to hospital

ARREST: similar results to ALIVE Neither trial designed or powered to evaluate

survival to discharge Occurred in era of “poor CPR” (stacked shocks,

shock pauses of greater length, pulse checks) Late amiodarone! (given 21-25 after call

received, given 10 minutes after IV established)

ROC Amiodarone ScienceAmiodarone the drug

Amio insoluble in water, polysorbate 80 used as diluent

Makes amio difficult to deliver, drawn up from glass ampules then diluted before use

Tends to foam due to diluent Incompatible with solutions other then

D5W Diluent (as opposed to drug) causes

hypotension and phlebitis

ROC Amiodarone Science

Captisol-enabled amiodarone (pm101) New FDA approved formulation using

diluent (captisol) Diluent clear, hemo and electro inert Compatible with solutions other then D5W does not absorb in plastic pre filled syringe IV push immediately after IV established

ROC Amiodarone Methodology

Confirmed non traumatic cardiac arrest BLS CPR, analysis, shock and IV/IO

established After 1st shock**, CPR established,

vasopressor flush, study drug x 2 flush while ongoing CPR

2nd analysis if shockable> shock, CPR, advanced airway, vasopressor

3rd analysis if shockable> shock, CPR, study drug x1

ROC Amiodarone Methodology

Study Drug Kit Contents

ROC Amiodarone MethodologyRationale for lack of Rescue arm for

persistent VF/VT

Further open label doses may risk toxicity Require un-blinding in field (difficult) Neither study drug class 1 recommendation No preclusion to other treatments (EPI,

MAG, B Blocker, etc) Cross-over makes analysis more difficult

ROC Amiodarone EMS Challenges

Timing of Amiodarone delivery (voice, defib, guess!)

Tracking study kits, (remember ITDs!) Randomization Focus on early administration (new

approach to delivery) Local REB > will they allow a placebo

arm?

ROC Lactate

Prehospital lactate for the identification of shock in trauma

ROC Lactate Science

Recent prospective out-of-hospital research suggest HR and hypotension poor predictors of need for intervention in trauma

Hypotension late finding Delayed identification of hypo-perfusion

results in delayed definitive care

ROC Lactate Science Lactate biomarker of organ oxygen

supply/demand mismatch Elevated in sepsis, MI, trauma Historically only measured in hospital Now available point of care (POC) testing

of lactate level in prehospital care To date lactate testing predicts severity of

hemorrhage, mortality and need for ICU admission

ROC Lactate Science

Can POC testing be used as a triage tool?

Can we predict patients who will need resuscitative care that would not have been predicted otherwise?

ROC Lactate Methodology

Prospective observational study to identify patients suffering from hypo-perfusion secondary to trauma

Included patients meet local TT guidelines: BP < 100, Transported to level 1 or 2 trauma center Died in field or en route

Exclusions >isolated penetrating head injury

ROC Lactate Methodology

Patient identified, IV established, 50 micro liter (drop of blood) applied to POC lactate meter (similar to glucometer)

EMS blinded to result until reach ER No change in EMS treatment based on

POC testing Second lactate to be drawn in ER

ROC Lactate Methodology

ROC Lactate Meter

ROC Lactate EMS Challenges Pure ALS trial Need for trauma center transport Accurate documentation of lactate time of

draw Will medics un-blind and alter treatment? POC calibration POC tracking Blood sample after IV as opposed to

before

ROC Hypotensive Resuscitation

Field trial of hypotensive resuscitation vs. Standard resuscitation in patients with hemorrhagic shock after trauma-a pilot

study

ROC Hypotensive Resuscitation Science

Traditional treatment of trauma patients> aggressive fluid resuscitation to restore circulating volume, SBP

Increasing animal and human studies showing detrimental effects of massive fluid resus prior to hemorrhage control

Associated with cardiac dysfunction, abdominal compartment syndrome, ARDS, hypothermia and coagulopathy

ROC Hypotensive Resuscitation Science

Three RCTS, two observational studies suggest harm of aggressive fluid resuscitation as opposed to no prehospital fluids until hospital arrival

No study shows clear superiority of aggressive fluid resus vs hypotensive resuscitation yet aggressive fluid resus cornerstone of ATLS and PTLS teaching

RCT required to better answer the question

ROC Hypotensive Resuscitation Methodology

Patient with shock after trauma randomized to either standard or hypotensive Resusc arm

Inclusion: blunt or penetrating trauma, age> 15 or 50 kg, SBP < 90, absence of severe head injury or GCS >8

Exclusions (many)> fluid started by non ROC agency, ongoing CPR

ROC Hypotensive Resuscitation Methodology

Complete randomization (as opposed to a priori) Participating agencies carry pre randomized,

sealed, numbered containers Patient randomized and entered once container

opened Containers with 1000 cc or 250 cc iv normal

saline bags EMS will not know randomization until container

opened

ROC Hypotensive Resuscitation Methodology

• Tote bag to hold two Hypotensive Resusc fluid boxes

• Two cardboard boxes per tote will disguise/blind different size of IV fluid bags

ROC Hypotensive Resuscitation Methodology

Once container opened if 1000 cc bag randomized to control arm:

IV fluid given as rapidly as possible until ER arrival

If prehospital volume of 2 liters reached fluid stopped if

SBP >110

ROC Hypotensive Resuscitation Methodology

If container opened and 250 cc bag randomized to experimental group:

IV hung and if radial pulse or SBP > 70 TKVO fluids

no radial pulse or SBP < 70 begin 250 cc infusion until radial pulse returns or SBP 70

EMS agencies given option of using radial pulse or SBP as means of BP monitoring

ROC Hypotensive Resuscitation Methodology

ALS trial Significant in-hospital component Bong Canister technique Hypotensive resuscitation in severe head

injury? Tracking of treatment canisters

Other Studies At Various Levels

ROC Hypothermia (PreHospital Hypothermia)

ROC RESUCE (Estrogen Use In Trauma)

EMS Challenges For All ROC Trials

Competing non ROC research Training and training cycles REB approvals Multiple studies…which one do we choose? SMC requirements for continued participation Paramedic research burnout Long down time between recent HS and PRIMED

Questions?